FDA Adverse Event Summary report: N

SIGMA SPECTRUM

MDR report key: 3644150 · Received February 19, 2014

Report

Report Number
3644150
Date Received
February 19, 2014
Date of Event
January 16, 2014
Report Date
February 14, 2014
Manufacturer
BAXTER HEALTHCARE CORPORATION
Product Code
FRN
Report Source
User Facility report
Reporter Location
NC, US
Reporter Occupation
INVALID DATA

Narratives

Description of Event or Problem · 1

THE NURSE PROGRAMMED THE INFUSION PUMP TO INFUSE 1000 ML OVER THE COURSE OF 10 HOURS. AFTER BEGINNING THE TREATMENT AND VERIFYING EVERYTHING LOOKED GOOD, THE NURSE LEFT THE ROOM. LESS THAN TWO HOURS LATER THE IV BAG WAS EMPTY AND HAD INFUSED THE ENTIRE 1000 ML OF FLUID TO THE PATIENT. PUMP WAS REMOVED FROM PATIENT AND GIVEN TO BIOMED WITH TUBING AND IV BAG STILL IN PLACE. BIOMED FOUND THE TUBING IN THE CHANNEL KINKED AND BYPASSING THE FLOW SENSORS. BIOMEDICAL ENGINEERING HAS BEEN WORKING WITH SIGMA TO UNDERSTAND THE CAUSE. SOME KIND OF DRIED STICKY RESIDUE WAS FOUND, WHICH MAY HAVE CAUSED THE "PRESSURE PLATE" TO STICK AND ALLOW THE OVERINFUSION. BIOMEDICAL ENGINEERING BELIEVES THAT THE TUBING MAY HAVE BEEN COMPROMISED IN SOME WAY, POSSIBLY RESULTING IN A TINY PINHOLE WHICH DIRECTED FLUID TOWARDS THE AREA CLOSE TO THE LOWER PRESSURE PLATE. SIGMA IS PERFORMING A CHEMICAL ANALYSIS OF THE RESIDUE TO SEE WHAT IT WAS THAT GOT BACK THERE, BUT BELIEVES THAT THE REASON THE RESIDUE COULD ONLY BE FOUND IN THAT AREA AND NOT ANYWHERE ELSE IS BECAUSE SOMETHING SPILLED AND WAS CLEANED, AND THEN THE PUMP WAS SET AT AN ANGLE WHICH ALLOWED THE FLUID TO POOL. BIOMEDICAL ENGINEERING FEELS THERE ARE SOME INHERENT DESIGN PROBLEMS, PARTICULARLY WITH BEING ABLE TO CLOSE THE DOOR WHEN THE TUBING IS OFF-CENTERED, WHICH MAKE THIS POSSIBLE.====================== MANUFACTURER RESPONSE FOR INFUSION PUMP, (BRAND NOT PROVIDED) (PER SITE REPORTER) ====================== UNDER INVESTIGATION

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
105191 SIGMA SPECTRUM PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION 35700 *
105192 CONTINUFLO SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION * *

Patients

Seq Age Sex Outcome Treatment
1 82 YR BAXTER PUMP TUBING SET--"CLEAR LINK SYSTEM" "CONTI| NU-FLO SOLUTION SET"